Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209285
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB1 | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/23/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/21/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
05/21/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
CLONIDINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 0.1MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 203320 | ACTAVIS ELIZABETH |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209686 | AJANTA PHARMA LTD |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209285 | CHARTWELL RX |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 210338 | JUBILANT GENERICS |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209675 | NOVAST LABS |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB1 | 209757 | XIAMEN LP PHARM CO |